Comparing two methods for socket reconstruction and immediate dental implant placement

Clinical and Radiographic Evaluation of a Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials: a Multicentric Randomized Clinical Trial.

This study is testing whether using a special gel with a bone material during dental implant placement helps improve bone height better than using the bone material alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 22 Years to 70 Years
• Sex: All
• Sponsor: Università Vita-Salute San Raffaele (Academic / other)
• Locations: 1 site (Milan, Mi)
• Trial ID: NCT06517030 on ClinicalTrials.gov

What this trial studies

This clinical trial is a national multicentric prospective randomized controlled trial that aims to compare two different bone substitute materials used during socket reconstruction and immediate implant placement. Participants will be randomly assigned to receive either deproteinized bovine bone mineral combined with hyaluronic acid or deproteinized bovine bone mineral alone. The primary outcome is to assess the increase in vertical buccal bone height following the procedures. The study will adhere to the CONSORT guidelines to ensure high-quality reporting.

Who should consider this trial

Good fit: Ideal candidates are individuals requiring extraction of a single hopeless tooth in the maxillary or mandibular area, with sufficient buccal wall dehiscence.

Not a fit: Patients with autoimmune diseases, severe diabetes, or those on immunosuppressive therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve dental implant outcomes by enhancing bone height and stability.

How similar studies have performed: Previous studies have shown promising results with similar socket reconstruction techniques, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Participant is willing and able to give informed consent for participation in the trial.
2. In good general health as evidenced by medical history.
3. Presenting a single hopeless tooth candidate for extraction in the maxillary or mandibular area (from second premolar to second premolar, intercalated or the last tooth of dental arch) in need of a single implant-supported fixed prosthetic rehabilitation.
4. Presence of \>3mm of buccal wall dehiscence evaluated using Cone Beam Computed Tomography (CBCT).
5. In healthy periodontal conditions (i.e., no presence of sites ≥ 4 mm and/or presence of intra-bony defects in the selected sites, full mouth plaque score \< 20% and full-mouth bleeding score \< 20%).

Exclusion Criteria:

1. Current or previous use of immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
2. Presence of inflammatory and autoimmune disease of the oral cavity.
3. Severe or poorly controlled diabetes or previous radiotherapy of head area.
4. Contraindications to dental and/or surgical interventions (e.g. severe endocrine bone diseases, severe metabolic bone disorders, malignant tumour diseases).
5. Individuals who are smokers of \>10 cigarettes/day.
6. Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
7. Presence of \<3mm of dehiscence of buccal walls of the socket after tooth extraction.
8. Presence of a distance between the interdental bone crest and buccal bone crest \<3 mm after tooth extraction.

Where this trial is running

Milan, Mi

• Ospedale San Raffaele — Milan, Mi, Italy (Recruiting)

Study contacts

• Study coordinator: Giovanna Laura Di Domenico

Conditions Dental Implant